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Nevin Manimala Statistics

Comments on ‘standard and reference-based conditional mean imputation’: Regulators and trial statisticians be aware!

Pharm Stat. 2024 Apr 17. doi: 10.1002/pst.2373. Online ahead of print.

ABSTRACT

Accurate frequentist performance of a method is desirable in confirmatory clinical trials, but is not sufficient on its own to justify the use of a missing data method. Reference-based conditional mean imputation, with variance estimation justified solely by its frequentist performance, has the surprising and undesirable property that the estimated variance becomes smaller the greater the number of missing observations; as explained under jump-to-reference it effectively forces the true treatment effect to be exactly zero for patients with missing data.

PMID:38631678 | DOI:10.1002/pst.2373

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Nevin Manimala Statistics

Rejoinder to the letter: “Standard and reference-based conditional mean imputation: Regulators and trial statisticians be aware!”

Pharm Stat. 2024 Apr 17. doi: 10.1002/pst.2374. Online ahead of print.

NO ABSTRACT

PMID:38631676 | DOI:10.1002/pst.2374

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Nevin Manimala Statistics

Liraglutide 3.0 mg once daily for the treatment of overweight and obesity in patients hospitalised at a forensic psychiatric department: A 26-week open-label feasibility study

Acta Psychiatr Scand. 2024 Apr 17. doi: 10.1111/acps.13690. Online ahead of print.

ABSTRACT

INTRODUCTION: Overweight and obesity constitute a major concern among patients treated at forensic psychiatric departments. The present clinical feasibility study aimed at investigating the extent to which glucagon-like peptide 1 receptor agonist (GLP-1RA) treatment with once-daily liraglutide 3.0 mg could be a feasible pharmacological treatment of these conditions in patients with schizophrenia spectrum disorders hospitalised in forensic psychiatry.

METHODS: The 26-week, open-label feasibility study included participants aged 18-65 years diagnosed with a severe mental illness and hospitalised at a forensic psychiatric department. At the time of inclusion, all participants fulfilled the indication for using liraglutide as a treatment for overweight and obesity. Participants’ baseline examinations were followed by a 26-week treatment period with liraglutide injection once daily according to a fixed uptitration schedule of liraglutide, with a target dose of 3.0 mg. Each participant attended seven visits to evaluate the efficacy and adverse events. The primary endpoint was the number of “completers”, with adherence defined as >80% injections obtained in the period, weeks 12-26. Determining whether liraglutide is a feasible treatment was pre-defined to a minimum of 75% completers.

RESULTS: Twenty-four participants were included in the study. Sex, male = 19 (79.2%). Mean age: 42.3 [25th and 75th percentiles: 39.1; 48.4] years; body mass index (BMI): 35.7 [31.7; 37.5] kg/m2; glycated haemoglobin (HbA1c): 37 [35; 39] mmol/mol. Eleven out of 24 participants (46%) completed the study. For the completers, the median net body weight loss after 26 weeks of participation was -11.4 kg [-15.4; -5.9]. The net difference in HbA1C and BMI was -2.0 mmol/mol [-4; -1] and -3.6 kg/m2 [-4.7; -1.8], respectively. The weight change and reduction in HbA1c and BMI were all statistically significant from baseline.

CONCLUSION: The study did not confirm our hypothesis that liraglutide is a feasible treatment for a minimum of 75% of the patients initiating treatment with liraglutide while hospitalised in a forensic psychiatric department. The high dropout rate may be due to the non-naturalistic setting of the clinical trial. For the proportion of patients compliant with the medication, liraglutide 3.0 mg was an efficient treatment for overweight.

PMID:38631670 | DOI:10.1111/acps.13690

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Nevin Manimala Statistics

Economic implications of dural tears in lumbar microdiscectomies: a retrospective, observational study

World Neurosurg. 2024 Apr 15:S1878-8750(24)00615-6. doi: 10.1016/j.wneu.2024.04.052. Online ahead of print.

ABSTRACT

Retrospective cohort study. Level of Evidence Level III. Dural tears (DT) are a frequent complication after lumbar spine surgery. With this study we sought to determine the incidence of DT and the related impact on healthcare expenditures after lumbar discectomies. All patients with first-time single level lumbar discectomies at our institution that underwent minimally-invasive surgery from 2015 to 2019 were reviewed. Age, sex, weight, height, body mass index (BMI), costs, revenues, length of stay (LOS), American Society of Anesthesiology (ASA) score, Charlson Comorbidity Index (CCI) and operation time (OT) were assessed. Exclusion criteria were age < 18 years, previous spine surgery, multiple or traumatic disc herniations but also malignant and infectious diseases. The follow-up time was at least 12 months postoperatively. 358 patients with lumbar discectomies were identified and 230 met the inclusion criteria. The DT incidence was 3.5%. The mean costs (p < 0.001), the loss (p < 0.01) and the operation time (p < 0.0001) were found to be significantly higher in the DT group when compared to the control group of patients without a DT. The revenues were not statistically different between both groups (p > 0.05). Further analysis of the control group by profit and loss revealed significantly higher BMI (p < 0.05), LOS (p < 0.0001) and OT (p < 0.0001) in the loss group. DT represent a significant socioeconomic burden in lumbar spine surgery and cause severe secondary complications. The DT-related impact on healthcare expenses is primarily based on significantly higher OT and a higher mean LOS.

PMID:38631663 | DOI:10.1016/j.wneu.2024.04.052

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Nevin Manimala Statistics

Assessing the role of green investments and green innovation in ecological sustainability: From a climate action perspective on European countries

Sci Total Environ. 2024 Apr 15:172527. doi: 10.1016/j.scitotenv.2024.172527. Online ahead of print.

ABSTRACT

In recent years, economies have been increasingly focused on achieving the United Nations’ Sustainable Development Goals, recognizing that their achievement is vital to ecological sustainability and green growth. In this context, this paper focuses on investigating the impact of green innovation, green investment, economic growth, and natural resources on ecological sustainability in the five best-performing European Union countries in terms of the Climate Change Performance Index. This study uses the load capacity factor as a comprehensive proxy of ecological sustainability and also assesses the load capacity curve hypothesis in sample nations. Continuously updated fully modified and continuously updated bias-corrected estimators are used to analyze the data from 1995 to 2020 in the context of climate action perspective. The econometric analysis revealed that the load capacity curve hypothesis is invalid in the sample countries. Natural resources decrease environmental sustainability. However, green investments and green innovations contribute to environmental quality and thereby, can be used for effective climate action. Based on these findings, the study recommends specific policies to achieve the Sustainable Development Goals, with a particular focus on target 13.

PMID:38631639 | DOI:10.1016/j.scitotenv.2024.172527

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Nevin Manimala Statistics

Imidacloprid reduces the mating success of males in bumblebees

Sci Total Environ. 2024 Apr 15:172525. doi: 10.1016/j.scitotenv.2024.172525. Online ahead of print.

ABSTRACT

Bumblebees play a vital role in both natural and agricultural environments, however there has been a noticeable decline in their populations. Pesticides, particularly neonicotinoids, are widely regarded as a substantial contributing factor to the decline in bumblebee populations, as evidenced by the detrimental impacts documented across many stages of their life cycle. Mating is vital for the population maintenance of bumblebees. Nevertheless, there is a scarcity of research conducted on the effects of pesticides on the mating process. In this study, we individually examined the impact of imidacloprid on the mating behavior of bumblebee males and queens. A competitive mating experiment was conducted to evaluate the effect on the competitive prowess of male individuals and the mate selection behavior of female individuals. The study revealed that the mating rate of bumblebees exposed to a concentration of 10 ppb of imidacloprid was 3 %. This finding demonstrated a statistically significant impact when compared to the control group, which exhibited a mating rate of 58 % in the normal mating experiment. Furthermore, in the competitive mating experiment, we found that the competitive mating success rate of treated males (1 %) was significantly lower than that of untreated males (35 %). Hence, it provides evidence that neonicotinoid imidacloprid negatively affects bumblebee mating success and cautions us to protect bumblebees from pesticide exposure to prevent a severe impact on their populations.

PMID:38631635 | DOI:10.1016/j.scitotenv.2024.172525

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Nevin Manimala Statistics

Unraveling the mechanisms of Sofosbuvir resistance in HCV NS3/4A protease: Structural and molecular simulation-based insights

Int J Biol Macromol. 2024 Apr 15:131629. doi: 10.1016/j.ijbiomac.2024.131629. Online ahead of print.

ABSTRACT

Current management of HCV infection is based on Direct-Acting Antiviral Drugs (DAAs). However, resistance-associated mutations, especially in the NS3 and NS5B regions are gradually decreasing the efficacy of DAAs. Among the most effective HCV NS3/4A protease drugs, Sofosbuvir also develops resistance due to mutations in the NS3 and NS5B regions. Four mutations at positions A156Y, L36P, Q41H, and Q80K are classified as high-level resistance mutations. The resistance mechanism of HCV NS3/4A protease toward Sofosbuvir caused by these mutations is still unclear, as there is less information available regarding the structural and functional effects of the mutations against Sofosbuvir. In this work, we combined molecular dynamics simulation, molecular mechanics/Generalized-Born surface area calculation, principal component analysis, and free energy landscape analysis to explore the resistance mechanism of HCV NS3/4A protease due to these mutations, as well as compare interaction changes in wild-type. Subsequently, we identified that the mutant form of HCV NS3/4A protease affects the activity of Sofosbuvir. In this study, the resistance mechanism of Sofosbuvir at the atomic level is proposed. The proposed drug-resistance mechanism will provide valuable guidance for the design of HCV drugs.

PMID:38631585 | DOI:10.1016/j.ijbiomac.2024.131629

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Nevin Manimala Statistics

Analysis of X-ray irradiation effects on the mortality values and hemolymph immune cell composition of Apis mellifera and its parasite, Varroa destructor

J Invertebr Pathol. 2024 Apr 15:108109. doi: 10.1016/j.jip.2024.108109. Online ahead of print.

ABSTRACT

Varroa destructor is one of the most destructive enemies of the honey bee, Apis mellifera all around the world. Several control methods are known to control V. destructor, but the efficacy of several alternative control methods remains unexplored. Irradiation can be one of these unknown solutions but before practical application, the effectiveness, and the physiological effects of ionizing radiation on the host and the parasite are waiting to be tested. Therefore, the objective of our study was to investigate the effects of different doses (15, 50, 100, and 150 Gy) of high-energy X-ray irradiation through mortality rates and hemocyte composition changes in A. mellifera workers and record the mortality rates of the parasite. The mortality rate was recorded during short-term (12, 24, and 48 h) and long-term periods (3, 6, 12, 18, and 24d). The sensitivity of the host and the parasite in case of the higher doses of radiation tested (50, 100, and 150 Gy) been demonstrated by total mortality of the host and 90 % of its parasite has been observed on the 18th day after the irradiation. V. destructor showed higher sensitivity (1.52-times higher than the adult honey bee workers) at the lowest dose (15 Gy). A. mellifera hemocytes were influenced significantly by radiation dosage and the elapsed time after treatment. The higher radiation doses increased plasmatocyte numbers in parallel with the decrease in prohemocyte numbers. On the contrary, the numbers of granulocytes and oencoytes increased in the treated samples, but the putative effects of the different dosages on the recorded number of these hemocyte types could not be statistically proven. In summary, based on the outcome of our study X-ray irradiation can be deemed an effective tool for controlling phoretic V. destructor. However, further research is needed to understand the physiological response of the affected organisms.

PMID:38631557 | DOI:10.1016/j.jip.2024.108109

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Nevin Manimala Statistics

Adiposity and cartilage lesions following ACL reconstruction

Osteoarthritis Cartilage. 2024 Apr 15:S1063-4584(24)01153-1. doi: 10.1016/j.joca.2024.04.004. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine if global, central, or peripheral adiposity is associated with prevalent and worsening cartilage lesions following anterior cruciate ligament reconstruction (ACLR).

METHODS: In 107 individuals one-year post-ACLR, adiposity was assessed globally (body mass index, BMI), centrally (waist circumference), and peripherally (knee subcutaneous adipose tissue thickness) from magnetic resonance imaging (MRI). Tibiofemoral and patellofemoral cartilage lesions were assessed from knee MRIs at 1- and 5-years post-ACLR. Poisson regression evaluated the relation of adiposity with prevalent and worsening tibiofemoral and patellofemoral cartilage lesions adjusting for age, sex, and activity level.

RESULTS: The prevalence ratios of adiposity with tibiofemoral (presence in 49%) and patellofemoral (44%) cartilage lesions ranged from 0.99 to 1.03. Adiposity was more strongly associated with longitudinal changes in tibiofemoral (worsening in 21%) and patellofemoral (44%) cartilage lesions. One-unit increase in global (kg/m2), central (cm), and peripheral (mm) adiposity was associated with a higher risk of worsening tibiofemoral cartilage lesions by 17% (risk ratios [95% CI]: 1.17 [1.09 to 1.23]), 5% (1.05 [1.02 to 1.08]), and 9% (1.09 [1.03 to 1.16]), and patellofemoral cartilage lesions by 5% (1.05 [1.00 to 1.12]) 2% (1.02 [1.00 to 1.04]) and 2% (1.02 [1.00 to 1.04]), respectively.

CONCLUSION: Greater adiposity was a risk factor for worsening cartilage lesions up to 5 years post-ACLR. Clinical interventions aimed at mitigating excess adiposity may be beneficial in preventive approaches for early post-traumatic OA.

PMID:38631554 | DOI:10.1016/j.joca.2024.04.004

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Nevin Manimala Statistics

Ethnic Differences in Meat Consumption Attitudes, Norms and Behaviors: A Survey of White, South Asian and Black Ethnic Groups in the UK

Appetite. 2024 Apr 15:107359. doi: 10.1016/j.appet.2024.107359. Online ahead of print.

ABSTRACT

A reduction in meat consumption is necessary to mitigate negative impacts of climate change and adverse health outcomes. The UK has an increasingly multi-ethnic population, yet there is little research on meat consumption habits and attitudes among ethnic groups in the UK. We ran a survey (N=1014) with quota samples for ethnic groups and analyzed attitudes, behaviors and norm perceptions of White, South Asian and Black British respondents. Most respondents believe overconsumption of red and processed meat has negative impacts on health (73.3%) and the environment (64.3%).South Asian respondents were statistically significantly less likely to be meat eaters than White respondents (OR = .44, 95% CIs: .30-.65, t= -4.15, p= .000), while there was no significant difference between White and Black respondents (OR = 1.06, 95% CIs: .63-1.76, t= 0.21, p= .834). Both South Asian (OR = 2.76, 95% CIs: 1.89-4.03 t= 5.25, p= .000) and Black respondents (OR =2.09, 95% CIs: .1.30-3.35, t =3.06, p = .002) were significantly more likely to express being influenced by friends and family in their food choices than White respondents. South Asian (OR = 3.24 ,95% CIs: 2.17-4.84, t= 5.74, p= .000) and Black (OR = 2.02 ,95% CIs: 1.21-3.39, t= 2.69, p= .007) respondents were also both significantly more likely to report they would want to eat similarly to their friends and family than White respondents. Statistical analyses suggested some gender and socioeconomic differences across and among ethnic groups, which are reported and discussed. The differences in meat consumption behaviors and norm conformity between ethnic groups raises the prospect that interventions that leverage social norms may be more effective in South Asian groups than Black and White groups in the UK.

PMID:38631543 | DOI:10.1016/j.appet.2024.107359